Companion diagnostics (CDx)

Today there are a multitude of biomarkers that can be analyzed; DNA, RNA, proteins, metabolites… The search for the right biomarker can be long and tedious, leading to heavy development costs to identify the one capable of accurately, reliably and reproducibly predicting the response to treatment. Finding the ideal biomarker is therefore a challenge, and compromises seem to be necessary. In addition, there are other requirements such as ease of access to the biomarker, its detection method, its stability, etc.

How do we guide the search for a biomarker for a given treatment? What level of sensitivity/specificity should we aim for?

Historically, the technologies used in the context of CDx were mainly PCR as well as in situ hybridization (ISH) and immunohistochemistry (IHC). Recently, new approaches have been developed offering many advantages in terms of precision, reliability, speed or even accessibility of the biomarker. We can cite for example: next-generation sequencing (NGS), advanced medical imaging technologies coupled with artificial intelligence or “liquid biopsies”. The choice of technology may depend on the biomarker itself, but also on the maturity of the technology and its accessibility.

What balance should be struck between innovation, cost, ease of use and access? What is the level of knowledge and adoption of these technologies by healthcare professionals?

The companion diagnostics market remains new, and recent years have been marked by numerous regulatory changes. Additionally, government requirements may vary by region. A standardization of marketing processes between different countries would facilitate access to such tools, but we are a long way from that! In addition to this first level of difficulty, there is also the issue of the financial support model for these tests. Again, the modalities are often specific to each country.

Which business model should we adopt for a CDx? What regulatory process sequence should be followed to optimize companion diagnostic test launches?

Before engaging in the development of a CDx, a pharmaceutical company must answer many strategic questions, for which there is unfortunately no universal answer. Because it makes it possible to better target patients eligible for treatment, will a CDx reduce the population of target patients, or on the contrary expand it by identifying a pool of patients unknown until now? Will a CDx provide a differentiating competitive advantage or serve the entire therapeutic area? Is it more appropriate to consider a CDx in a lifecycle management logic, or at launch? These are all business questions we address for our clients.

How do we evaluate the market potential of a CDx and the competitive advantage it provides? Which product in the portfolio is the most relevant to develop a companion diagnostic? How can we evaluate the return on investment of these innovations for the pharmaceutical company and for the company that will develop the test?

The majority of players in the pharmaceutical industry who wish to address the personalized medicine market have no choice today but to partner with diagnostic players to develop a test in conjunction with their treatment. The creation of partnerships seems inevitable given the skills required to launch such an activity.

In a market where several major players such as Roche Diagnostics, Qiagen or Abbott Diagnostics compete, how do we identify the right partner? Who are the new players? How is the value distributed between partners?

The co-development model is a major challenge for pharmaceutical companies wishing to market a treatment associated with a CDx. In order to optimize its launch, it is essential to ensure the synchronization of the development process of the drug and the test, and their evaluation, production, distribution and reimbursement. This synchronization can be particularly difficult. Finally, there is a significant gap between the development time of a CDx and that of a drug, which further complicates the development and marketing strategy.

How do we build a process/action plan to coordinate these different steps? How do we integrate a CDx into a drug development and launch plan?